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Solar Water Disinfection Intervention Trial in Bolivia

NCT00731497 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1163

Last updated 2017-12-19

No results posted yet for this study

Summary

The importance of waterborne gastrointestinal illness throughout the developing world, the existence of a cheap and effective intervention (SODIS), the concurrent limited dissemination program for SODIS, the need for a controlled evaluation of the effectiveness of SODIS under actual field conditions, and the experience of our tri-national collaborative research team in successfully conducting large scale drinking water intervention and observational studies in both the United States and the developing world encourage us to propose the following randomized controlled trial in which our specific aims are to:

* Evaluate the hypothesis that SODIS reduces the incidence of gastrointestinal illness in 660 children under the age of five years in rural Bolivia that are randomly selected from 22 villages ;
* Define, through an extensive microbiologic testing component, the baseline rates of pathogen-specific diarrheal illnesses and the pathogens responsible for the differences in diarrheal illness between active and control groups;
* Document the actual use and acceptance of SODIS by participants in the study;
* Assess the cost-effectiveness of SODIS and the social and economic impact of SODIS at household level;
* Examine through mathematical disease modelling the effects of the presence of multiple transmission pathways within a village on the preventable fraction estimate due to the introduction of SODIS.

Conditions

Interventions

DEVICE

Solar Water Disinfection (SODIS)

Intervention group has SODIS implemented at the household level as a way to disinfect drinking water

Sponsors & Collaborators

Principal Investigators

  • John M Colford, M.D., Ph.D. · U.C. Berkeley

  • Daniel Mausezahl, Ph.D. · Swiss Tropical & Public Health Institute

  • Andri Christen · Bolivia

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
5 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2004-09-30
Primary Completion
2006-06-30
Completion
2006-06-30

Countries

  • Bolivia

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00731497 on ClinicalTrials.gov